The implementation of new rules on medical devices should avoid extra burdens and unnecessary bureaucracy, health industry officials have told euractiv.com.
Medical devices and in vitro diagnostic medical devices cover a wide range of products, such as sticking plasters, hip replacements, state-of-the-art pacemakers, X-ray machines pregnancy, and genetic tests.
It is estimated that there are over 500,000 medical and in vitro diagnostic devices on the market while the sector employs over 500,000 people in about 25,000 companies.
On 25 May, the Netherlands Presidency of the Council and representatives of the European Parliament reached a political agreement and agreed new rules on medical devices and in vitro diagnostic medical devices.
The new rules still need to be approved by the Council’s Permanent Representatives Committee most probably in mid-June as well as the European Parliament’s ENVI committee.
Under constant scrutiny
The two draft regulations emphasise the need to make medical devices and in vitro diagnostic medical devices safer for consumers by establishing a monitoring system before and after entering the EU market.
Particularly, rules on placing devices on the market are tightened as well as surveillance, once they become available for use.
According to the Dutch EU Presidency, the new rules will make it easier for the independent bodies that are responsible for assessing medical devices “to carry out unannounced factory inspections” before these devices get access to the EU market. In addition, manufacturers will be responsible for the “follow-up of the quality, performance and safety of devices placed on the market” as well as register complaints on devices.
Another figure of the new rules is the fact that high-risk devices, such as implants, will be subject to additional check by experts, while additional devices without a medical purpose are covered, such as fillers and coloured contact lenses for cosmetic purposes.
The new rules also provide setting up a “central database” in order to increase the traceability of medical devices on the market.
“A unified European database of medical devices will be built and each devices will be identified by a unique code, in order to be traced for surveillance- an assurance of safety and effectiveness,” Dr Carlo Favaretti, President of the European Public Health Association Section on Health Technology Assessment, told EURACTIV.
This database will cover economic operators, notified bodies, market surveillance, vigilance, clinical investigations and certificates, while devices will have a unique identification number to provide for traceability throughout the supply chain to the end-user or patient.
Industry wants balanced implementation
Medtech Europe, an alliance of European medical technology industry associations, believes that there is a great deal of work remaining after the regulations have been adopted and published.
“There will be many secondary pieces of legislation to follow – in particular, the implementing and delegating acts,” John Brennan, Regulatory Affairs Director at MedTech Europe, told euractiv.com, adding that the legislation should avoid “unnecessary” red tape.
“MedTech Europe hopes that these acts will be able to translate this complex framework into feasible and implementable rules that deliver safety and avoids unnecessary bureaucracy for all parties involved.”
“For now, we are still awaiting the texts of the regulation to understand the details that were agreed. Once we receive the texts, we will be able to identify the details that medical device and diagnostic companies need to know in order to comply with the new regulations,” Brennan stressed.
The European Trade Association representing the medical imaging, radiotherapy, health ICT, and electromedical industries (COCIR) shares a similar view.
Nicole Denjoy, COCIR Secretary General, told EURACTIV that the political agreement was an important step that brings the process closer to its conclusion and possible adoption.
“However, we still believe that there will be some important work, once adopted during the implementation phase that will require realistic rules for regulators, industry and other stakeholders, avoiding unnecessary burden,” she said, urging for the Medical Devices Regulation to be implemented in a “balanced manner”.
“It must not hamper innovations from our industries while keeping a highest level of safety and quality for patients and citizens,” Denjoy told EURACTIV.
A missed chance
Contacted by EURACTIV, the European Consumer Organization (BEUC) expressed its satisfaction for the deal, citing that once the medical devices will be on the market, it will be easier to monitor them.
Ilaria Passarani, Head of the Food & Health department at BEUC, noted though that the EU missed an opportunity for a more thorough assessment of devices before the devices are marketed.
“It is also a pity we still have to wait a few years before we see the changes happen on the ground and truly benefit consumers,” she stressed, as the new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.
“This agreement matters to all citizens: sooner or later all of us enter into contact with medical devices to diagnose, prevent, treat or alleviate diseases. The deal reached will improve patients' health and it will help to enhance the quality of life of disabled persons. It will also ensure a level playing field for the 25,000 medical devices manufacturers in the EU, many of which are SMEs and which employ more than half a million persons,” Edith Schippers, Minister of Health of the Netherlands and President of the Council, said.
According to Dr. Carlo Favaretti, President of the European Public Health Association Section on Health Technology Assessment, views the new rules in positive light.
He told EURACTIV that the improvement is based on:
- Safety of the devices has to be assured at the moment of their production but also in the post-marketing phase through a European surveillance system
- Clinical data provision is mandatory both in pre- than in post-marketing phase: there is a sort of proportional (incremental) duty in data provision based on risk of different devices (data on efficacy/effectiveness are not mandatory in the present regulations)
- Manufacturer is in charge of quality, performance and safety of the devices
- The regeneration of medical devices will be allowed (under certain rules) and this will be an important harmonisation of national regulation (i.e. in Germany it is already allowed, in Italy it is not) and it will positively impact on costs.
Medical devices are defined broadly and can include anything from sticking plasters to contact lenses, pregnancy tests, dental filling materials, X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
Following a huge health scandal involving faulty breast implants sold around Europe, the European Commission published proposals in late 2012 for a new regulatory regime for medical devices.
On 25 May 2016, the EU agreed new rules on medical devices and in vitro diagnostic medical devices.
The Netherlands presidency of the Council and representatives of the European Parliament reached a political agreement.
It is still subject to the approval by the Council's Permanent Representatives Committee and of the Parliament's ENVI committee.
- Mid-June 2016: The Council's Permanent Representatives Committee expected to endorse the agreement.